Albumin is used to treat patients with severe burns, shock or blood loss. It is also used to supplement media used for growing higher eukaryotic cells and as an excipient for pharmacologically active compounds, many of which need to be stabilised. At present, the demand for the product is satisfied by albumin extracted from human blood. Examples of extraction and separation techniques include those disclosed in: JP 03/258 728 on the use of a cation exchanger; EP 428 758 on the use of anion exchange; and EP 452 753 on the use of heating, adding salt and diafiltering.
The production of rHA in micro-organisms has been disclosed in EP 330 451 and EP 361 991. Purification techniques for rHA have been disclosed in: WO 92/04367, removal of matrix-derived dye; EP 464 590, removal of yeast-derived colorants; EP 319 067, alkaline precipitation and subsequent application of the rHA to a lipophilic phase; and WO 96/37515, which contains several complete purification processes.
The present invention represents the result of intensive development of the processes described in WO 96/37515 and that of U.S. Pat. No. 5,728,553, incorporated herein by reference.